FDA clarifies LibiGel requirements for BioSante
LINCOLNSHIRE, Ill. BioSante Pharmaceuticals Tuesday morning revealed that it has received clarity from the Food and Drug Administration on key FDA requirements for the development and approval of LibiGel in the treatment of female sexual dysfunction.
Presently, there are no pharmaceutical treatments for FSD and only one over-the-counter solution on the market.
BioSante met with FDA representatives from the Division of Reproductive and Urologic Products, the Division of Cardio-Renal Products and the Office of Biometrics III (earlier this summer. According to BioSante, the primary focus of the meeting was BioSante’s LibiGel safety study protocol to evaluate the cardiovascular risk of using testosterone in women, a key pre-approval concern of the FDA.
“We are quite gratified by the outcome of our communications with the FDA,” stated Stephen Simes, BioSante’s president and chief executive officer. “We were confident that we had submitted a proposal that provided the depth and scope of study requested by the FDA. The agreement with FDA has reaffirmed our long-held belief that development of LibiGel could be both reasonable and affordable from both the financial and timeline aspects. We have received written FDA meeting minutes that provide us with a clearly defined LibiGel development path that can lead to the approval of LibiGel for the treatment of FSD. In the U.S., no pharmaceutical product is approved for the treatment of FSD making this a truly underserved market. BioSante is committed to the development of LibiGel which ultimately may be the first product approved by the FDA for this treatment in the U.S.”
In addition to two Phase III efficacy trials, BioSante will conduct one Phase III cardiovascular safety study. The safety study will be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. A new drug application can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval, BioSante will continue to follow the women enrolled in the study for an additional four years.
If successful with its BioSante, the resulting approval will raise awareness around FSD not only for LibiGel as a prescription solution, but also for Helm Pharmaceutical’s OTC remedy Vibrel.
Vibrel works through its transdermal delivery system of niacin, an essential B vitamin known for its vasodilation properties. The effects of the niacin are realized through the GlycoTransDelivery System, a proprietary structural matrix that ensures the stability and tolerability of the compound, increases blood flow to the genitals, adds lubrication and creates a sense of warmth.
Vibrel works through its transdermal delivery system of niacin, an essential B vitamin known for its vasodilation properties. The effects of the niacin are realized through the GlycoTransDelivery System, a proprietary structural matrix that ensures the stability and tolerability of the compound, increases blood flow to the genitals, adds lubrication and creates a sense of warmth.
Helm Pharmaceuticals has doubled Vibrel’s distribution in the past year (Vibrel is expected to reach 15,000 doors of distribution by year’s end) and plans to continue differentiating its product among OB/GYN’s as a product that helps alleviate FSAD as opposed to being just a personal lubricant.